More setbacks for Bydureon (exenatide)
October 29, 2010
In Part 2 of the Weekly Summary show, Jay Skyler, MD, leads the discussion about the surprise setbacks to approval for the diabetes drug Bydureon (long-acting exenatide) to be marketed by Eli Lilly and Amylin Pharmaceuticals. After answering the data required in the first Complete Response letter from the FDA, the agency issued another CR letter asking for more data on QT-prolongation.
Topics discussed include:
- Was the FDA influenced by the Avandia saga?
- The details of what is now requested about the extra QT data
- Is the drug industry going to shy away from new diabetes drugs given the burdensome FDA requirements?
Diabetes, Endocrinology, Internal medicine, The Lancet, The Weekly Summary, Univ Miami | apples49 | 
November 3, 2010 1:30 pm
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